GeoVax Labs, Inc. (OTC Bulletin Board: GOVX), announced today the expansion of the Phase 2a clinical trial testing of its HIV/AIDS vaccine products. The expanded Phase 2a trial will test the administration of three doses of the recombinant poxvirus vaccine MVA62B without the use of the recombinant DNA-vectored vaccine, which was used to prime immune responses in the first part of this trial. At the completion of the trial, 150 participants will have received the vaccine products using two DNA inoculations followed by two MVA inoculations, 75 participants will have received the vaccine using three MVA inoculations and 75 participants will have received placebo. Enrollment into the expanded Phase 2a trial opened December 6th.
GeoVax is developing two vaccine components: a recombinant DNA-vectored vaccine and a recombinant MVA-vectored vaccine. Both produce non-infectious virus-like particles in the body of a vaccine recipient. These non-infectious particles are designed to "train" the immune system of the vaccinated person to recognize HIV should the vaccinated person be exposed to the real virus. Both the DNA and MVA vaccines induce humoral (antibody) and cellular (cytotoxic T cell) responses. Antibodies have the potential to block virus before it infects cells. The cytotoxic T cells have the potential to recognize and kill virus-infected cells. The vaccine is designed to control clade B HIV infections. Clade B HIV is found in North, Central and parts of South America, Western Europe, Australia and Japan.
"I like the simplicity of using the MVA-vectored vaccine alone because it is a regimen that could easily be taken forward for the world. The data from our Phase 1 clinical trial and recent preclinical data obtained using a non-human primate model support the use of this simplified vaccine regimen," said Harriet Robinson, the GeoVax Chief Scientific Officer.
The expanded Phase 2a trial is sponsored by the National Institute of Allergy and Infectious Diseases, part of the US National Institutes of Health, and is conducted by the HIV Vaccine Trials Network (HVTN). The HVTN is the largest worldwide clinical trials network dedicated to the development and testing of HIV/AIDS vaccines. The trial bears the same HVTN 205 designation as the original Phase 2a trial.
SOURCE GeoVax Labs, Inc.